Case Study:

Major University Needs Regulatory Guidance and Compliance Oversight

Our Client:

A major university discovered a need for regulatory guidance and compliance oversight.

Safis cleared up regulatory misconceptions with the FDA. We also worked with the quality manager to build the quality system and assisted with SOPs and other record documentation to clarify and update their compliance status.

Safis’ efforts enabled the facility to establish substantial equivalence for a medical device and receive a 510k notification letter from the FDA. The device is the only one of its type in the Midwest that provides another form of therapy for cancer patients.

The device has improved the quality of life for patients undergoing treatment, as well as saving the life of an individual who helped build it.